Celltrion Inc

Celltrion Inc. received FDA approval for Steqeyma (ustekinumab), a biosimilar of Stelara, for psoriasis vulgaris, psoriatic arthritis, Crohn's Disease, and Ulcerative Colitis in the US. The drug is already approved in South Korea, Europe, the UK, Canada, and other countries. Celltrion anticipates finalizing a patent settlement to enter the US market by February.

FDA approves Celltrion's STEQEYMA (ustekinumab-stba), a biosimilar to STELARA, for treating plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis in adults and pediatric patients. STEQEYMA is expected to be marketed in the U.S. in February 2025.

South Korea leads in biopharmaceutical industry with companies like Celltrion and Samsung Bioepis dominating biosimilars market. 24 biosimilars from South Korean companies are approved globally, with 11 being monoclonal antibodies. Celltrion is a leader in deal-making, contributing to South Korea's influence in global biosimilars landscape.

Celltrion Inc. launches Celltrion BioSolutions Co., entering the CDMO market with plans to build a 800 billion won plant in Korea, targeting 3 trillion won in sales by 2031. The unit aims to differentiate with a variety of drug modalities and CGT services.

Celltrion secures three biosimilar approvals from EMA's CHMP, while Biocon Biologics and Aurobindo's CuraTeQ also gain positive opinions for biosimilars.

FDA approves Steqeyma (ustekinumab-stba), a biosimilar to Stelara, for treating plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis in adults and pediatric patients. Steqeyma demonstrated high similarity to its reference product in terms of safety and efficacy.

EMA's CHMP recommended marketing authorization for Celltrion's biosimilars Eydenzelt (aflibercept), Stoboclo and Osenvelt (denosumab), and Avtozma (tocilizumab). Eydenzelt treats retinal disorders like wet AMD, DME, and myopic CNV. The European Commission will decide on marketing authorization.

Health Canada approved Celltrion's Omlyclo, the first omalizumab biosimilar in Canada, for treating chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps. Omlyclo demonstrated bioequivalence to Xolair in a phase 3 study, and is under FDA review. Celltrion also received positive CHMP opinions for three other biosimilars in Europe.

The EMA CHMP gave positive opinions for Celltrion's three biosimilars, including Eydenzelt (biosimilar aflibercept), Stoboclo and Osenvelt (biosimilar denosumab), and Avtozma (biosimilar tocilizumab). The European Commission will decide on marketing authorisations. Eydenzelt is recommended for treating multiple retinal disorders and met equivalence criteria in a Phase III study. Celltrion's Taehun Ha emphasized the company's commitment to affordable, high-quality treatments in Europe.